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TDMS Study 96007-05 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 05                                                                                     TIME: 11:36:29       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007F       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 57117-31-4      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                  FINAL #3/CONTROL VS. STOP GROUPS                                                  
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 NG/KG                                                                       
                                       INCLUDE 007    200 NG/ KG STOP                                                               
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 05                                                                                     TIME: 11:36:29       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007F       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 57117-31-4      
Rats(SPRAGUE-DAWLEY)                                                                                                                
-----------------------------                                                                                                       
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE                                                                   
BASED ON NUMBER OF TISSUES EXAMINED.  IN OTHER TISSUES/ORGANS RATES                                                                 
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Cortex                                                                     
                                                 Adrenal Medulla                                                                    
                                                 Heart                                                                              
                                                 Kidney                                                                             
                                                 Liver                                                                              
                                                 Ovary                                                                              
                                                 Pancreas                                                                           
                                                 Pituitary Gland                                                                    
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 05                                                                                     TIME: 11:36:29       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007F       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 57117-31-4      
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF       TOXIC EQUIVALENCY FACTOR EVALUATION(                                                                       
===============================================================                                                                     
Female Rats                                                                                                                         
------------                                                                                                                        
Organ                                  Morphology                                                                                   
-----                                  ----------                                                                                   
Adrenal Medulla                        Pheochromocytoma Benign                                                                      
                                       Pheochromocytoma: Benign, Complex, Malignant, NOS                                            
Mammary Gland                          Adenoma                                                                                      
                                       Carcinoma                                                                                    
                                       Carcinoma or Adenoma                                                                         
                                       Fibroadenoma                                                                                 
                                       Fibroma, Fibroadenoma or Adenoma                                                             
                                       Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                 
Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                          
                                       Squamous Cell Carcinoma                                                                      
                                       Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                    
Oral Mucosa                            Squamous Cell Carcinoma                                                                      
Pancreas                               Carcinoma or Adenoma                                                                         
Pituitary Gland: Pars Distalis or Unspecified Site                                                                                  
                                       Adenoma                                                                                      
Skin                                   Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma                 
                                       Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                  
Thyroid Gland: C-Cell                  Adenoma                                                                                      
                                       Carcinoma                                                                                    
                                       Carcinoma or Adenoma                                                                         
Uterus                                 Adenoma                                                                                      
                                       Polyp Stromal                                                                                
All Organs                             Benign Tumors                                                                                
                                       Malignant Tumors                                                                             
                                       Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 1       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)        -        TOXIC EQUIVALENCY FACTOR EVALUATION(                 
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma Benign                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              4/53 (8%)                                         1/48 (2%)                    | 
|POLY-3 RATE (b)    |                              4/42.04                                           1/32.61                      | 
|POLY-3 PERCENT (g) |                              9.5%                                              3.1%                         | 
|TERMINAL (d)       |                              3/25 (12%)                                        1/15 (7%)                    | 
|FIRST INCIDENCE    |                              659                                               728 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.348N                     | 
|POLY 3             |                                                                                P=0.286N                     | 
|POLY 1.5           |                                                                                P=0.256N                     | 
|POLY 6             |                                                                                P=0.325N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.300N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.214N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Adrenal Medulla                                                                                                                  | 
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         1/48 (2%)                    | 
|POLY-3 RATE (b)    |                              5/42.04                                           1/32.61                      | 
|POLY-3 PERCENT (g) |                              11.9%                                             3.1%                         | 
|TERMINAL (d)       |                              4/25 (16%)                                        1/15 (7%)                    | 
|FIRST INCIDENCE    |                              659                                               728 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.245N                     | 
|POLY 3             |                                                                                P=0.186N                     | 
|POLY 1.5           |                                                                                P=0.161N                     | 
|POLY 6             |                                                                                P=0.218N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.203N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.127N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 2       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION(                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              1/41.78                                           2/33.36                      | 
|POLY-3 PERCENT (g) |                              2.4%                                              6.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              728 (T)                                           610                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.352                      | 
|POLY 3             |                                                                                P=0.453                      | 
|POLY 1.5           |                                                                                P=0.464                      | 
|POLY 6             |                                                                                P=0.442                      | 
|LOGISTIC REGRESSION|                                                                                P=0.411                      | 
|COCH-ARM / FISHERS |                                                                                P=0.478                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              5/53 (9%)                                         5/50 (10%)                   | 
|POLY-3 RATE (b)    |                              5/42.44                                           5/33.62                      | 
|POLY-3 PERCENT (g) |                              11.8%                                             14.9%                        | 
|TERMINAL (d)       |                              3/25 (12%)                                        4/15 (27%)                   | 
|FIRST INCIDENCE    |                              619                                               500                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.339                      | 
|POLY 3             |                                                                                P=0.497                      | 
|POLY 1.5           |                                                                                P=0.535                      | 
|POLY 6             |                                                                                P=0.454                      | 
|LOGISTIC REGRESSION|                                                                                P=0.471                      | 
|COCH-ARM / FISHERS |                                                                                P=0.592                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 3       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION(                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              6/53 (11%)                                        7/50 (14%)                   | 
|POLY-3 RATE (b)    |                              6/42.44                                           7/34.03                      | 
|POLY-3 PERCENT (g) |                              14.1%                                             20.6%                        | 
|TERMINAL (d)       |                              4/25 (16%)                                        5/15 (33%)                   | 
|FIRST INCIDENCE    |                              619                                               500                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.191                      | 
|POLY 3             |                                                                                P=0.346                      | 
|POLY 1.5           |                                                                                P=0.387                      | 
|POLY 6             |                                                                                P=0.303                      | 
|LOGISTIC REGRESSION|                                                                                P=0.314                      | 
|COCH-ARM / FISHERS |                                                                                P=0.455                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroadenoma                                                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              34/53 (64%)                                       34/50 (68%)                  | 
|POLY-3 RATE (b)    |                              34/49.74                                          34/42.97                     | 
|POLY-3 PERCENT (g) |                              68.4%                                             79.1%                        | 
|TERMINAL (d)       |                              14/25 (56%)                                       9/15 (60%)                   | 
|FIRST INCIDENCE    |                              289                                               276                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.057                      | 
|POLY 3             |                                                                                P=0.171                      | 
|POLY 1.5           |                                                                                P=0.238                      | 
|POLY 6             |                                                                                P=0.132                      | 
|LOGISTIC REGRESSION|                                                                                P=0.353                      | 
|COCH-ARM / FISHERS |                                                                                P=0.419                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 4       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION(                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma or Adenoma                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              35/53 (66%)                                       34/50 (68%)                  | 
|POLY-3 RATE (b)    |                              35/49.74                                          34/42.97                     | 
|POLY-3 PERCENT (g) |                              70.4%                                             79.1%                        | 
|TERMINAL (d)       |                              15/25 (60%)                                       9/15 (60%)                   | 
|FIRST INCIDENCE    |                              289                                               276                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.069                      | 
|POLY 3             |                                                                                P=0.232                      | 
|POLY 1.5           |                                                                                P=0.309                      | 
|POLY 6             |                                                                                P=0.186                      | 
|LOGISTIC REGRESSION|                                                                                P=0.420                      | 
|COCH-ARM / FISHERS |                                                                                P=0.499                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Mammary Gland                                                                                                                    | 
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              38/53 (72%)                                       36/50 (72%)                  | 
|POLY-3 RATE (b)    |                              38/50.41                                          36/42.97                     | 
|POLY-3 PERCENT (g) |                              75.4%                                             83.8%                        | 
|TERMINAL (d)       |                              16/25 (64%)                                       11/15 (73%)                  | 
|FIRST INCIDENCE    |                              289                                               276                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.069                      | 
|POLY 3             |                                                                                P=0.227                      | 
|POLY 1.5           |                                                                                P=0.335                      | 
|POLY 6             |                                                                                P=0.153                      | 
|LOGISTIC REGRESSION|                                                                                P=0.454                      | 
|COCH-ARM / FISHERS |                                                                                P=0.574                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 5       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION(                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       | 
|     Squamous Cell Carcinoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              1/41.78                                           3/33.25                      | 
|POLY-3 PERCENT (g) |                              2.4%                                              9.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              728 (T)                                           680                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.179                      | 
|POLY 3             |                                                                                P=0.249                      | 
|POLY 1.5           |                                                                                P=0.263                      | 
|POLY 6             |                                                                                P=0.236                      | 
|LOGISTIC REGRESSION|                                                                                P=0.192                      | 
|COCH-ARM / FISHERS |                                                                                P=0.287                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)                                                                       | 
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              1/41.78                                           3/33.25                      | 
|POLY-3 PERCENT (g) |                              2.4%                                              9.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              728 (T)                                           680                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.179                      | 
|POLY 3             |                                                                                P=0.249                      | 
|POLY 1.5           |                                                                                P=0.263                      | 
|POLY 6             |                                                                                P=0.236                      | 
|LOGISTIC REGRESSION|                                                                                P=0.192                      | 
|COCH-ARM / FISHERS |                                                                                P=0.287                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 6       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION(                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Oral Mucosa                                                                                                                      | 
|     Squamous Cell Carcinoma                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              1/53 (2%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              1/41.78                                           3/33.25                      | 
|POLY-3 PERCENT (g) |                              2.4%                                              9.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         1/15 (7%)                    | 
|FIRST INCIDENCE    |                              728 (T)                                           680                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.179                      | 
|POLY 3             |                                                                                P=0.249                      | 
|POLY 1.5           |                                                                                P=0.263                      | 
|POLY 6             |                                                                                P=0.236                      | 
|LOGISTIC REGRESSION|                                                                                P=0.192                      | 
|COCH-ARM / FISHERS |                                                                                P=0.287                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pancreas                                                                                                                         | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/49 (4%)                    | 
|POLY-3 RATE (b)    |                              0/41.78                                           2/32.92                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              6.1%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         2/15 (13%)                   | 
|FIRST INCIDENCE    |                              ---                                               728 (T)                      | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.134                      | 
|POLY 3             |                                                                                P=0.215                      | 
|POLY 1.5           |                                                                                P=0.220                      | 
|POLY 6             |                                                                                P=0.212                      | 
|LOGISTIC REGRESSION|                                                                                P=0.134                      | 
|COCH-ARM / FISHERS |                                                                                P=0.228                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 7       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION(                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              15/53 (28%)                                       13/49 (27%)                  | 
|POLY-3 RATE (b)    |                              15/43.22                                          13/34.20                     | 
|POLY-3 PERCENT (g) |                              34.7%                                             38.0%                        | 
|TERMINAL (d)       |                              8/25 (32%)                                        5/15 (33%)                   | 
|FIRST INCIDENCE    |                              603                                               610                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.267                      | 
|POLY 3             |                                                                                P=0.488                      | 
|POLY 1.5           |                                                                                P=0.557                      | 
|POLY 6             |                                                                                P=0.421                      | 
|LOGISTIC REGRESSION|                                                                                P=0.397                      | 
|COCH-ARM / FISHERS |                                                                                P=0.509N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        | 
|     or Fibrous Histiocytoma                                                                                                     | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         3/50 (6%)                    | 
|POLY-3 RATE (b)    |                              0/41.78                                           3/34.88                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              8.6%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.100                      | 
|POLY 3             |                                                                                P=0.099                      | 
|POLY 1.5           |                                                                                P=0.104                      | 
|POLY 6             |                                                                                P=0.094                      | 
|LOGISTIC REGRESSION|                                                                                P=0.188                      | 
|COCH-ARM / FISHERS |                                                                                P=0.111                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 8       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION(                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Skin                                                                                                                             | 
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              0/53 (0%)                                         2/50 (4%)                    | 
|POLY-3 RATE (b)    |                              0/41.78                                           2/34.73                      | 
|POLY-3 PERCENT (g) |                              0.0%                                              5.8%                         | 
|TERMINAL (d)       |                              0/25 (0%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              ---                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.222                      | 
|POLY 3             |                                                                                P=0.219                      | 
|POLY 1.5           |                                                                                P=0.223                      | 
|POLY 6             |                                                                                P=0.215                      | 
|LOGISTIC REGRESSION|                                                                                P=0.390                      | 
|COCH-ARM / FISHERS |                                                                                P=0.233                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              13/53 (25%)                                       5/48 (10%)                   | 
|POLY-3 RATE (b)    |                              13/43.49                                          5/33.34                      | 
|POLY-3 PERCENT (g) |                              29.9%                                             15.0%                        | 
|TERMINAL (d)       |                              8/25 (32%)                                        3/15 (20%)                   | 
|FIRST INCIDENCE    |                              500                                               525                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.211N                     | 
|POLY 3             |                                                                                P=0.111N                     | 
|POLY 1.5           |                                                                                P=0.084N                     | 
|POLY 6             |                                                                                P=0.149N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.097N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.055N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 9       
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION(                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma                                                                                                                   | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/48 (0%)                    | 
|POLY-3 RATE (b)    |                              2/41.78                                           0/32.61                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              0.0%                         | 
|TERMINAL (d)       |                              2/25 (8%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              728 (T)                                           ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.356N                     | 
|POLY 3             |                                                                                P=0.331N                     | 
|POLY 1.5           |                                                                                P=0.306N                     | 
|POLY 6             |                                                                                P=0.363N                     | 
|LOGISTIC REGRESSION|                                                                                (e)                          | 
|COCH-ARM / FISHERS |                                                                                P=0.273N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Thyroid Gland: C-Cell                                                                                                            | 
|     Carcinoma or Adenoma                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              15/53 (28%)                                       5/48 (10%)                   | 
|POLY-3 RATE (b)    |                              15/43.49                                          5/33.34                      | 
|POLY-3 PERCENT (g) |                              34.5%                                             15.0%                        | 
|TERMINAL (d)       |                              10/25 (40%)                                       3/15 (20%)                   | 
|FIRST INCIDENCE    |                              500                                               525                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.121N                     | 
|POLY 3             |                                                                                P=0.049N*                    | 
|POLY 1.5           |                                                                                P=0.035N*                    | 
|POLY 6             |                                                                                P=0.070N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.047N*                    | 
|COCH-ARM / FISHERS |                                                                                P=0.021N*                    | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 10      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION(                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Adenoma                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              2/53 (4%)                                         0/50 (0%)                    | 
|POLY-3 RATE (b)    |                              2/41.97                                           0/32.95                      | 
|POLY-3 PERCENT (g) |                              4.8%                                              0.0%                         | 
|TERMINAL (d)       |                              1/25 (4%)                                         0/15 (0%)                    | 
|FIRST INCIDENCE    |                              678                                               ---                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.338N                     | 
|POLY 3             |                                                                                P=0.331N                     | 
|POLY 1.5           |                                                                                P=0.300N                     | 
|POLY 6             |                                                                                P=0.368N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.307N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.262N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              9/53 (17%)                                        4/50 (8%)                    | 
|POLY-3 RATE (b)    |                              9/43.07                                           4/34.77                      | 
|POLY-3 PERCENT (g) |                              20.9%                                             11.5%                        | 
|TERMINAL (d)       |                              4/25 (16%)                                        1/15 (7%)                    | 
|FIRST INCIDENCE    |                              588                                               451                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.324N                     | 
|POLY 3             |                                                                                P=0.224N                     | 
|POLY 1.5           |                                                                                P=0.189N                     | 
|POLY 6             |                                                                                P=0.268N                     | 
|LOGISTIC REGRESSION|                                                                                P=0.168N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.141N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 11      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION(                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              45/53 (85%)                                       40/50 (80%)                  | 
|POLY-3 RATE (b)    |                              45/50.55                                          40/43.88                     | 
|POLY-3 PERCENT (g) |                              89.0%                                             91.2%                        | 
|TERMINAL (d)       |                              21/25 (84%)                                       13/15 (87%)                  | 
|FIRST INCIDENCE    |                              289                                               276                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.080                      | 
|POLY 3             |                                                                                P=0.511                      | 
|POLY 1.5           |                                                                                P=0.640                      | 
|POLY 6             |                                                                                P=0.409                      | 
|LOGISTIC REGRESSION|                                                                                P=0.587N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.346N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              12/53 (23%)                                       13/50 (26%)                  | 
|POLY-3 RATE (b)    |                              12/43.55                                          13/36.43                     | 
|POLY-3 PERCENT (g) |                              27.6%                                             35.7%                        | 
|TERMINAL (d)       |                              7/25 (28%)                                        5/15 (33%)                   | 
|FIRST INCIDENCE    |                              377                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.145                      | 
|POLY 3             |                                                                                P=0.301                      | 
|POLY 1.5           |                                                                                P=0.353                      | 
|POLY 6             |                                                                                P=0.249                      | 
|LOGISTIC REGRESSION|                                                                                P=0.364                      | 
|COCH-ARM / FISHERS |                                                                                P=0.433                      | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  09/30/03                           EXPERIMENT: 96007 TEST: 05                                            Page 12      
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY)       -        TOXIC EQUIVALENCY FACTOR EVALUATION(                  
                                         Terminal Sacrifice at 104 weeks                                                            
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |                              0 NG/KG                                           200 NG/                      | 
|                   |                                                                                KG STOP                      | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |                              #                                                 #                            | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |                              48/53 (91%)                                       43/50 (86%)                  | 
|POLY-3 RATE (b)    |                              48/51.69                                          43/45.66                     | 
|POLY-3 PERCENT (g) |                              92.9%                                             94.2%                        | 
|TERMINAL (d)       |                              22/25 (88%)                                       14/15 (93%)                  | 
|FIRST INCIDENCE    |                              289                                               240                          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |                                                                                P=0.069                      | 
|POLY 3             |                                                                                P=0.577                      | 
|POLY 1.5           |                                                                                P=0.619N                     | 
|POLY 6             |                                                                                P=0.437                      | 
|LOGISTIC REGRESSION|                                                                                P=0.509N                     | 
|COCH-ARM / FISHERS |                                                                                P=0.339N                     | 
|ORDER RESTRICTED   |                                                                                (e)                          | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(d)  Observed incidence at terminal kill.                                                                                           
(f)  Beneath the control incidence are the P-values associated with the trend                                                       
test.  Beneath the dosed group incidence are the P-values corresponding to                                                          
pairwise comparisons between the controls and that dosed group.  The life                                                           
table analysis regards tumors in animals dying prior to  terminal kill as                                                           
 being (directly or indirectly) the cause of death.                                                                                 
Logistic regression is an alternative                                                                                               
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage                                                       
and Fishers exact tests compare directly the overall incidence rates                                                                
For all tests a negative trend is indicated by N                                                                                    
(e)  Value of Statistic cannot be computed.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(I)  Interim sacrifice                                                                                                              
(T)  Terminal sacrifice                                                                                                             
#   Tumor rates based on number of animals necropsied.                                                                              
*   To the right of any statistical result, indicates significance at (P<=0.05).                                                    
**  To the right of any statistical result, indicates significance at (P<=0.01).